Hemkortin-hc

Patient Information Leaflet

Hemkortin-HC
10 mg + 10 mg, suppositories
Hydrocortisoni acetas + Zinci sulfas
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor, pharmacist, or nurse.
• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement within 3–4 days, or if your condition worsens, consult your doctor.

Table of Contents:

1. What Hemkortin-HC is and what it is used for
2. Important information before using Hemkortin-HC
3. How to use Hemkortin-HC
4. Possible side effects
5. How to store Hemkortin-HC
6. Contents of the pack and other information

1. What Hemkortin-HC is and what it is used for

Hemkortin-HC suppositories contain hydrocortisone, which has anti-inflammatory properties, and zinc sulfate, which has an astringent effect. The medicine reduces swelling and inflammation of the anal region, helps control bleeding, and relieves itching.
Hemkortin-HC suppositories are indicated for the treatment of haemorrhoids, inflammatory conditions of the anus, anal fissures, and anal pruritus. They may be used in pre- and post-operative management.

2. Important information before using Hemkortin-HC

When not to use Hemkortin-HC:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has diabetes, tuberculosis, glaucoma, osteoporosis, acute psychosis, fungal or viral infections, or venous thrombosis.

Warnings and precautions
Before starting treatment with Hemkortin-HC, discuss this with your doctor or pharmacist.
If any of the situations described below apply to the patient, he or she should discuss them with a doctor before starting treatment with Hemkortin-HC.
The patient should exercise particular caution when using Hemkortin-HC if:

• he or she has a concurrent infection, allergy, or other symptoms – appropriate causal treatment should then be administered;
• he or she is undergoing vaccinations or immunotherapy – the medicine should not be used at that time;
• he or she experiences symptoms of irritation – use of the medicine should then be discontinued;
• he or she is using the medicine long-term – systemic effects characteristic of corticosteroids may occur, although with low probability;
• he or she experiences rectal bleeding – medical advice should be sought immediately;
• he or she has previously used hydrocortisone – this should be reported to the doctor;
• he or she experiences blurred vision or other visual disturbances – contact the doctor.

If treatment is ineffective, consult a doctor.
Children
Use of the medicine in children under 12 years of age is contraindicated.
Pregnancy
Consult a doctor before using this medicine.
Animal studies have shown teratogenic and embryotoxic effects of hydrocortisone. There are unconfirmed data suggesting a risk of cleft palate, intrauterine growth retardation, and suppressive effects on the hypothalamic-pituitary-adrenal axis in fetuses exposed to hydrocortisone administered to pregnant women. Therefore, Hemkortin-HC may be used in pregnant women only if absolutely necessary, following careful evaluation by the doctor of risks and benefits.
Breast-feeding
Consult a doctor before using this medicine.
Hemkortin-HC should not be used during breast-feeding due to the risk of growth suppression in the infant caused by hydrocortisone.
Driving and operating machinery:
The effect of the medicine on the ability to drive motor vehicles and operate mechanical equipment has not been studied.
Hemkortin-HC and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to take, even those available without a prescription.
Exercise particular caution when using Hemkortin-HC together with any of the following medicines:
Non-steroidal anti-inflammatory drugs or acetylsalicylic acid – may cause gastric and duodenal ulcers, gastrointestinal ulceration, or bleeding. Caution is recommended in patients with hypoprothrombinemia when corticosteroids are used concomitantly with acetylsalicylic acid.
Phenytoin – the therapeutic effect of corticosteroids may be reduced due to enhanced metabolism and decreased plasma concentration of the drug. This is caused by induction of hepatic microsomal enzymes by phenytoin. In such cases, an increased dose of corticosteroids may be required.
Vaccines, live viruses, or other immunizations – the use of corticosteroids during vaccination is not recommended due to increased risk of neurological complications after vaccination and possible reduction in antibody levels or lack of immune response.
Some medicines may enhance the effect of Hemkortin-HC, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Pregnancy and breast-feeding
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Hemkortin-HC may be used in pregnant women only if absolutely necessary, following careful evaluation by the doctor of risks and benefits.
Hemkortin-HC should not be used during breast-feeding due to the risk of growth suppression in the infant caused by hydrocortisone.
Driving and operating machinery
The effect of the medicine on the ability to drive and operate machinery has not been studied.

3. How to use Hemkortin-HC

Always use exactly as described in the patient leaflet or as directed by the physician.
If in doubt, consult a doctor or pharmacist.
In adults, one suppository is usually administered in the morning, one in the evening, and after each bowel movement.
Use for three to four days, or until the inflammatory condition subsides. If there is no improvement within this time or if the patient's condition worsens, consult a doctor.
Method of administration
Tear open the suppository packaging, remove the suppository, and gently insert it into the rectum with the pointed end first.
Overdose of Hemkortin-HC
No cases of poisoning have been reported. In case of accidental ingestion of suppositories, gastric lavage is recommended.
If an overdose is taken or if suppositories are accidentally swallowed, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
A burning sensation in the anal area may occasionally occur, especially if the skin is significantly damaged.
With prolonged use, adverse effects caused by the systemic action of hydrocortisone may occur.
Adverse reactions occurring with unknown frequency: blurred vision.
Other adverse reactions may occur in some individuals during treatment with this medicine.
If you experience any adverse effects not listed in this leaflet, inform your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including those not mentioned in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Hemkortin-HC
Keep the medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date (EXP) refers to the last day of the stated month.

6. Contents of the package and other information

What Hemkortin-HC contains
The active substances in this medicine are: hydrocortisone acetate and zinc sulfate.
Each suppository contains:
active substances:
10 mg hydrocortisone acetate
10 mg zinc sulfate monohydrate
excipient:
hard fat (Witepsol)

What Hemkortin-HC looks like and contents of the pack
A cardboard box containing 12 suppositories in 2 blisters of 6 pieces each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Polmex Pharma Biniecki sp. k., Pokorna 2 lok. 1027, 00-199 Warsaw, Poland
Tel. 22 636 23 79

Manufacturer
Fulton Medicinali S.p.A., Via Marconi 28/9, Arese (MI), Italy

For further information, please contact the Marketing Authorisation Holder.